NCT00533390

Brief Summary

Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800 mg dose would be more adequate than the 600mg

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

5.8 years

First QC Date

September 19, 2007

Last Update Submit

November 7, 2015

Conditions

TuberculosisHIV Infections

Keywords

efavirenztuberculosisAIDSrifampicinefficacysafetyTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group

    6 months

Secondary Outcomes (1)

  • Immunologic reconstitution Genotyping resistance

    6 months

Study Arms (2)

EFAVIRENZ 800mg

EXPERIMENTAL

Efavirenz 800 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin

Drug: efavirenz

EFAVIRENZ 600mg

ACTIVE COMPARATOR

Efavirenz 600 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin

Drug: efavirenz

Interventions

efavirenzDRUG

600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS

Also known as: Stocrin, Sustiva
EFAVIRENZ 600mgEFAVIRENZ 800mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with tuberculosis diagnosis, HIV positive.
  • Agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent)

You may not qualify if:

  • Active liver disease
  • Pregnancy or breast feeding
  • CD4 counts \>350

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal do Espirito Santo

Vitória, Espírito Santo, Brazil

Location

FIOCRUZ Instituto de Pesquisa Clinica Evandro Chagas

Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil

Location

MeSH Terms

Conditions

TuberculosisHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Valeria C Rolla, MD DSc

    Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

    PRINCIPAL INVESTIGATOR

  • Maria Cristina S Lourenço, MSc

    Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

    STUDY CHAIR

  • Flávia M Sant'Anna, MSc

    Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

    STUDY CHAIR

  • Mariza G Morgado, DSc

    Instituto Oswaldo Cruz, Fiocruz

    STUDY CHAIR

  • Pedro E Americano do Brasil, MD MSc

    Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

    STUDY CHAIR

  • Carolina S Smaltz, PhD student

    Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

    STUDY CHAIR

  • Jose L Teixeira, Pharmacist

    Instituto de pesquisa Clinica Evandro Chagas

    STUDY CHAIR

  • David J Hadad, PhD

    Federal University of Espirito Santo

    STUDY CHAIR

  • Reynaldo Dietze, PhD

    Federal University of Espirito Santo

    STUDY CHAIR

  • Moises Palaci, PhD

    Federal University of Espirito Santo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

BR(2)